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FDA 510(k)

Broncoflex Agile, Broncoflex Vortex, Screeni

K-Number: K212886 · 2022-02-16

ApplicantAxess Vision Technology
Decision Date2022-02-16
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Broncoflex Agile, Broncoflex Vortex, Screeni is a medical device manufactured by Axess Vision Technology. It received FDA 510(k) clearance on 2022-02-16 under approval number K212886. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Broncoflex Agile, Broncoflex Vortex, Screeni?

Broncoflex Agile, Broncoflex Vortex, Screeni is a medical device that received FDA 510(k) clearance on 2022-02-16. It is manufactured by Axess Vision Technology. The 510(k) number is K212886.

When was Broncoflex Agile, Broncoflex Vortex, Screeni approved by the FDA?

Broncoflex Agile, Broncoflex Vortex, Screeni received FDA 510(k) clearance on 2022-02-16, under approval number K212886.

What company makes Broncoflex Agile, Broncoflex Vortex, Screeni?

Broncoflex Agile, Broncoflex Vortex, Screeni is manufactured by Axess Vision Technology.

What is the FDA product code for Broncoflex Agile, Broncoflex Vortex, Screeni?

The FDA product code for Broncoflex Agile, Broncoflex Vortex, Screeni is EOQ.

Other Devices by Axess Vision Technology

K202180Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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